Thyroid NoduleDillNCT04482907
Effect of Dill in Thyroiditis and Nodular Goiter Patients
A study of Thyroid Nodule, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the functional and morphological effects of Anethum graveolens L. in patients with thyroiditis and nodular goiter by evaluating hormone levels, anti-Inflammatory markers and comparing thyroid nodule sizes measured by ultrasonography for 90 days. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Thyroid Nodule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 5 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To have multi-nodular goiter,
- To be a benign result in fine needle aspiration biopsy,
- Euthyroid must be sick,
- Must be sick over the age of 18,
- To accept the research.
Who cannot join
- Thyroid function tests non-euthyroid individuals,
- To have a malignant result in thyroid biopsy,
- Not giving approval,
- To be renal failure,
- Benign pregnant,
- Taking blood thinning drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Placebo Controlled Clinical Study of Anethum Graveolens L. (Dill) in Thyroiditis and Nodular Goiter Patients
The aim of the study was to investigate the functional and morphological effects of Anethum graveolens L. in patients with thyroiditis and nodular goiter by evaluating hormone levels, anti-Inflammatory markers and comparing thyroid nodule sizes measured by ultrasonography for 90 days.
The effect of Anethum graveolens L. was evaluated in euthyroid goiter patients diagnosed with benign thyroid nodule via fine needle aspiration biopsy. Aerial parts of Anethum graveolens L. were dried and grinded to yield a fine powder. Size 1 hydroxypropyl methylcellulose capsules were filled with 300 mg powder. Placebo was prepared in the same manner using maltodextrin. Patients were suggested to take 3 pills a day. Blood samples were collected at the initial and the final day for thyroid stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (Anti-Tg) and C-reactive protein (CRP) analysis. Nodule sizes were also measured at the beginning and at the end of the trial with ultrasonography to identify the changes and effectiveness of dill dosage forms.
Read more
After 90 days in the study, the status of TSH, fT3, fT4, anti-TPO and CRP levels were examined in the group with and without Anethum graveolens L..
Again, after the study, the size of thyroid nodules was evaluated in the group who received and did not receive Anethum graveolens L. by ultrasonography.
- Conditions
- Thyroid Nodule
- Being tested
- Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.
- Keywords
- Anethum graveolens L., Thyroiditis, Nodular Goiter
- Medical subject headings
- Thyroid Nodule, Thyroiditis, Goiter, Nodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.Dietary supplement
Also called Taking blood from the arm intravenously at the beginning and end of the study and looking for thyroid hormones from this blood.
Tests from intravenous blood: TSH, fT3, fT4, anti-TPO, Anti-Tg, CRP
| Study group | Role | What they receive |
|---|---|---|
| Group receiving dill | Active comparator | They took 3 meals a day, 3x300 mg dry dill powder by mouth. They bought dry dill powder for 90 days. Receives: Dietary Supplement: Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group. |
| Group receiving placebo | Placebo comparator | They took 3 meals a day and 3 cellulose placebo capsules by mouth. They took placebo capsules for 90 days. Receives: Dietary Supplement: Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of thyroid stimulating hormone (TSH) between groups
At the beginning and at the end of the study, the levels of serum TSH were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Measured: 90 days
Comparison of free triiodothyronine (fT3) between groups
At the beginning and at the end of the study, the levels of serum fT3 were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Measured: 90 days
Comparison of free thyroxine (fT4) between groups
At the beginning and at the end of the study, the levels of serum fT4 were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Measured: 90 days
Comparison of anti-thyroid peroxidase (anti-TPO) between groups
At the beginning and at the end of the study, the levels of anti-TPO were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Measured: 90 days
Comparison of anti-thyroglobulin (Anti-Tg) between groups
At the beginning and at the end of the study, the levels of serum Anti-Tg were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Measured: 90 days
Comparison of C-reactive protein (CRP) between groups
At the beginning and at the end of the study, the levels of serum CRP were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Measured: 90 days
Comparison of ultrasound and thyroid nodule sizes between groups
At the beginning and end of the study, thyroid nodule sizes (mm) were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Feb 2019
- Primary completion16 Dec 2019
- Study completion5 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups were created. Patients with thyroid nodules were divided into two groups given dill and placebo. The study was planned for 90 days. 900 mg of powder dill was given daily to the dill group. Placebo was given to the control group. Serum thyroid stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (Anti-Tg) and C-reactive protein (CRP) levels of both groups were examined at the beginning and at the end of the study. Thyroid nodule dimensions were measured at the beginning and at the end of the study by ultrasonography. The results were evaluated statistically.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayşegul Yabacı, research, Study chair, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482907
- Sponsor's protocol ID
- 12.2014/21
- Acronym
- Dill
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When published as a full article in a journal indexed, IPD will be shared.
Publications
Jana S, Shekhawat GS. Anethum graveolens: An Indian traditional medicinal herb and spice. Pharmacogn Rev. 2010 Jul;4(8):179-84. doi: 10.4103/0973-7847.70915.
PubMed 22228959Orhan IE, Senol FS, Ozturk N, Celik SA, Pulur A, Kan Y. Phytochemical contents and enzyme inhibitory and antioxidant properties of Anethum graveolens L. (dill) samples cultivated under organic and conventional agricultural conditions. Food Chem Toxicol. 2013 Sep;59:96-103. doi: 10.1016/j.fct.2013.05.053. Epub 2013 Jun 10.
PubMed 23764360Antonelli A, Ferrari SM, Corrado A, Di Domenicantonio A, Fallahi P. Autoimmune thyroid disorders. Autoimmun Rev. 2015 Feb;14(2):174-80. doi: 10.1016/j.autrev.2014.10.016. Epub 2014 Oct 25.
PubMed 25461470Kratky J, Vitkova H, Bartakova J, Telicka Z, Antosova M, Limanova Z, Jiskra J. Thyroid nodules: pathophysiological insight on oncogenesis and novel diagnostic techniques. Physiol Res. 2014;63 Suppl 2(Suppl 2):S263-75. doi: 10.33549/physiolres.932818.
PubMed 24908232Yang ML, Lu B. Treatment of Goiter with Traditional Chinese Medicine Regimen Xing Qi Hua Ying Tang: A Clinical Study on 72 Patients with Multinodular and Diffuse Goiter. J Altern Complement Med. 2018 Apr;24(4):374-377. doi: 10.1089/acm.2017.0138. Epub 2017 Dec 7.
PubMed 29215302Altay M, Ates I, Kaplan Efe F, Karadag I. Does Use of Anethum Graveolens Affected Thyroid Hormone Levels and Thyroid Nodules? Am J Ther. 2017 Sep/Oct;24(5):e627-e629. doi: 10.1097/MJT.0000000000000511. No abstract available.
PubMed 27753646
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo Controlled Clinical Study of Anethum Graveolens L. (Dill) in Thyroiditis and Nodular Goiter Patients
- ClinicalTrials.gov ID
- NCT04482907
- Acronym / sponsor ID
- Dill / 12.2014/21
- Conditions
- Thyroid Nodule
- Keywords
- Anethum graveolens L., Thyroiditis, Nodular Goiter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to investigate the functional and morphological effects of Anethum graveolens L. in patients with thyroiditis and nodular goiter by evaluating hormone levels, anti-Inflammatory markers and comparing thyroid nodule sizes measured by ultrasonography for 90 days.
The effect of Anethum graveolens L. was evaluated in euthyroid goiter patients diagnosed with benign thyroid nodule via fine needle aspiration biopsy. Aerial parts of Anethum graveolens L. were dried and grinded to yield a fine powder. Size 1 hydroxypropyl methylcellulose capsules were filled with 300 mg powder. Placebo was prepared in the same manner using maltodextrin. Patients were suggested to take 3 pills a day. Blood samples were collected at the initial and the final day for thyroid stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (Anti-Tg) and C-reactive protein (CRP) analysis. Nodule sizes were also measured at the beginning and at the end of the trial with ultrasonography to identify the changes and effectiveness of dill dosage forms.
After 90 days in the study, the status of TSH, fT3, fT4, anti-TPO and CRP levels were examined in the group with and without Anethum graveolens L..
Again, after the study, the size of thyroid nodules was evaluated in the group who received and did not receive Anethum graveolens L. by ultrasonography.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups were created. Patients with thyroid nodules were divided into two groups given dill and placebo. The study was planned for 90 days. 900 mg of powder dill was given daily to the dill group. Placebo was given to the control group. Serum thyroid stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (Anti-Tg) and C-reactive protein (CRP) levels of both groups were examined at the beginning and at the end of the study. Thyroid nodule dimensions were measured at the beginning and at the end of the study by ultrasonography. The results were evaluated statistically.
| Arm | Type | Receives |
|---|---|---|
| Group receiving dill | Active comparator | Dietary Supplement: Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.They took 3 meals a day, 3x300 mg dry dill powder by mouth. They bought dry dill powder for 90 days. |
| Group receiving placebo | Placebo comparator | Dietary Supplement: Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.They took 3 meals a day and 3 cellulose placebo capsules by mouth. They took placebo capsules for 90 days. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To have multi-nodular goiter,
- To be a benign result in fine needle aspiration biopsy,
- Euthyroid must be sick,
- Must be sick over the age of 18,
- To accept the research.
Key exclusion criteria (6 listed)
- Thyroid function tests non-euthyroid individuals,
- To have a malignant result in thyroid biopsy,
- Not giving approval,
- To be renal failure,
- Benign pregnant,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.Also: Taking blood from the arm intravenously at the beginning and end of the study and looking for thyroid hormones from this blood.Tests from intravenous blood: TSH, fT3, fT4, anti-TPO, Anti-Tg, CRP | Dietary supplement | Group receiving dill, Group receiving placebo |
Primary outcome
Comparison of thyroid stimulating hormone (TSH) between groups
Time frame: 90 days
At the beginning and at the end of the study, the levels of serum TSH were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Comparison of free triiodothyronine (fT3) between groups
Time frame: 90 days
At the beginning and at the end of the study, the levels of serum fT3 were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Comparison of free thyroxine (fT4) between groups
Time frame: 90 days
At the beginning and at the end of the study, the levels of serum fT4 were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Comparison of anti-thyroid peroxidase (anti-TPO) between groups
Time frame: 90 days
At the beginning and at the end of the study, the levels of anti-TPO were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Comparison of anti-thyroglobulin (Anti-Tg) between groups
Time frame: 90 days
At the beginning and at the end of the study, the levels of serum Anti-Tg were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Comparison of C-reactive protein (CRP) between groups
Time frame: 90 days
At the beginning and at the end of the study, the levels of serum CRP were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Comparison of ultrasound and thyroid nodule sizes between groups
Time frame: 90 days
At the beginning and end of the study, thyroid nodule sizes (mm) were measured and statistically compared in groups given Anethum graveolens L. and placebo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Results publication: PubMed 22228959Jana S, Shekhawat GS. Anethum graveolens: An Indian traditional medicinal herb and spice. Pharmacogn Rev. 2010 Jul;4(8):179-84. doi: 10.4103/0973-7847.70915.
- Results publication: PubMed 23764360Orhan IE, Senol FS, Ozturk N, Celik SA, Pulur A, Kan Y. Phytochemical contents and enzyme inhibitory and antioxidant properties of Anethum graveolens L. (dill) samples cultivated under organic and conventional agricultural conditions. Food Chem Toxicol. 2013 Sep;59:96-103. doi: 10.1016/j.fct.2013.05.053. Epub 2013 Jun 10.
- Results publication: PubMed 25461470Antonelli A, Ferrari SM, Corrado A, Di Domenicantonio A, Fallahi P. Autoimmune thyroid disorders. Autoimmun Rev. 2015 Feb;14(2):174-80. doi: 10.1016/j.autrev.2014.10.016. Epub 2014 Oct 25.
- Results publication: PubMed 24908232Kratky J, Vitkova H, Bartakova J, Telicka Z, Antosova M, Limanova Z, Jiskra J. Thyroid nodules: pathophysiological insight on oncogenesis and novel diagnostic techniques. Physiol Res. 2014;63 Suppl 2(Suppl 2):S263-75. doi: 10.33549/physiolres.932818.
- Results publication: PubMed 29215302Yang ML, Lu B. Treatment of Goiter with Traditional Chinese Medicine Regimen Xing Qi Hua Ying Tang: A Clinical Study on 72 Patients with Multinodular and Diffuse Goiter. J Altern Complement Med. 2018 Apr;24(4):374-377. doi: 10.1089/acm.2017.0138. Epub 2017 Dec 7.
- Results publication: PubMed 27753646Altay M, Ates I, Kaplan Efe F, Karadag I. Does Use of Anethum Graveolens Affected Thyroid Hormone Levels and Thyroid Nodules? Am J Ther. 2017 Sep/Oct;24(5):e627-e629. doi: 10.1097/MJT.0000000000000511. No abstract available.
- Individual participant dataSharing planned: No. When published as a full article in a journal indexed, IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşegul Yabacı, research study chair
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Thyroid Nodule, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of thyroid stimulating hormone (TSH) between groups (time frame: 90 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482907, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.